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Efgartigimod alfa / hyaluronidase-qvfc

Vyvgart Hytrulo

Extended indication Extension of indication to include the treatment of adult patients with chronic inflammatory demyeli
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Efgartigimod alfa / hyaluronidase-qvfc
Domain Neurological disorders
Reason of inclusion Indication extension
Main indication Neurological disorders other
Extended indication Extension of indication to include the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) with active disease despite treatment with corticosteroids or immunoglobulins
Proprietary name Vyvgart Hytrulo
Manufacturer Argenx
Mechanism of action Receptor antagonist
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks FcRn-blokker

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date June 2024
Expected Registration August 2025
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options IVIg of SCIg
Therapeutic value No estimate possible yet
Duration of treatment Average 25 week / weeks
Frequency of administration 1 times a week
Dosage per administration 1.008 mg / 11.200 units (1.008 mg efgartigimod alfa and 11.200 units hyaluronidase)
References NCT04281472 (ARGX-113-1802) (1); Vyvgart Hytrulo prescribing information (2).
Additional remarks The recommended dosage of VYVGART HYTRULO is 1,008mg / 11,200 units (1,008mg efgartigimod alfa and 11,200 units hyaluronidase) administered subcutaneously over approximately 30 to 90 seconds as once weekly injections. The mean duration of treatment with VYVGART HYTRULO in stage B was 25 weeks.

Expected patient volume per year

References Orphanet (1); Fabrikant (2).
Additional remarks De prevalentie van chronische inflammatoire demyeliniserende polyneuropathie voor volwassenen bedraagt 1 tot 7 op de 100.000 volwassenen, maar algemeen wordt aangenomen dat dit onderschattingen zijn (1). De fabrikant verwacht 80 tot 100 patiënten in Nederland (2).

Expected cost per patient per year

Cost < 376,350.00
References Drugs.com (1)
Additional remarks In de Verenigde Staten liggen de kosten van Vyvgart Hytrulo (qvfc 180mg-2000 units/mL) rond de $16,618 voor een flacon van 5,6ml (1). Uitgaande van een behandeling van 25 weken met een wekelijkse injectie van een flacon kan een schatting gemaakt worden van € 376.350 per patiënt per jaar (€ 15.054*25).

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.